NCT06813898RecruitingEarly phase 1
An Investigational Scan (rhPSMA-7.3 PET/CT) for Detecting Biochemically Recurrent Prostate Cancer, ENLIGHTEN Trial
ENLIGHTEN: Detection by POSLUMA Following Negative Other PET-PSMA Imaging
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
This phase II trial evaluates an imaging technique (rhPSMA-7.3 positron emission tomography \[PET\]/computed tomography \[CT\]) for detecting prostate cancer in patients who have increasing prostate-specific antigen levels following prior treatment (biochemical recurrence) but who were prostate specific membrane antigen negative on their most recent PET scan. Contrast agents like rhPSMA-7.3 (also called POSLUMA) circulate in the blood until they find their intended target. Once they are taken up by the target tumor cells, they can be visualized using PET/CT cameras. A PET scan is a procedure in which a small amount of radioactive tracer (in this case rhPSMA-7.3) is injected into a vein, and a scanner is used to make detailed, computerized pictures of areas inside the body where the tracer is taken up. Because tumor cells often take up more tracer than normal cells, the pictures can be used to find tumor cells in the body. A CT scan is a procedure that uses a computer linked to an x-ray machine to make a series of detailed pictures of areas inside the body. The pictures are taken from different angles and are used to create 3-dimensional views of tissues and organs. Combining a PET scan with a CT scan can help make the image easier to interpret. PET/CT scans are hybrid scanners that combine both modalities into a single scan during the same examination. The researchers want to determine whether the rhPSMA7.3 PET/CT scan is useful for detecting biochemically recurrent prostate cancer in patients who were negative on prior non-POSLUMA PET imaging.
- Status (registry)
- Recruiting
- Phase (registry)
- Early phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 3 Feb 2025
- Start date
- 11 Apr 2025
- Primary completion date
- 1 Feb 2027
- Lead sponsor
- Northwestern University
- Diseases
- Prostate cancer, Childhood cancers
- NCT number
- NCT06813898
What you commit to
- Study type: Interventional · Early phase 1
- Planned participants: 27
- From 11 Apr 2025 to the primary completion date, 1 Feb 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients receiving 5-alpha reductase inhibitors, androgen deprivation therapy and androgen receptor antagonists within 3 months of enrollment (men may start these therapies at physician discretion immediately following POSLUMA PET PSMA scan)
Other illness
- Men with non-metastatic castrate resistant prostate cancer (defined as rising PSA and T \< 50ng/dl)
Other
- Most recent PSA not between 0.1ng/ml and 0.5ng/ml
Who the study is looking for
- Men with a history of prostate adenocarcinoma treated with local therapy (including radical prostatectomy or radical prostatectomy and secondary therapy \[i.e. salvage radiation\])
- Men must have biochemical recurrence (defined as PSA \>= 0.1ng/ml) after therapy
- PSA \< 0.5ng/ml (within 90 days of enrollment)
- Men must have had negative or equivocal PET PSMA based imaging with 90 days of enrollment with an Food and Drug Administration (FDA) approved non-POSLUMA tracer
- Non-castrate testosterone (testosterone \[T\] \> 50ng/dL) within 90 days of study entry
- Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures
- Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study
- Concurrent diseases and malignancies are permitted
Sex: Male · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Northwestern University Coordinator of this site? Confirm its status | Chicago | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.